Cleanroom space is a necessary component for the development and manufacture of biotech products. For example, 21 CFR 210-211 describes the current Good Manufacturing Practices (cGMP) regulations that must be followed in the manufacturing, processing, packaging or holding of a drug product. These regulations require that equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature must be provided, and that air filtration systems must be used on air supplies to production areas. If air is recirculated, the regulations require that measures must be taken to control recirculation of dust from production, and in areas where air contamination occurs during production, there must be adequate exhaust systems or other systems adequate to control contaminants.
Entities in the business of developing and manufacturing biotech products typically have permanent cleanrooms and/or other appropriate facilities devoted to product development and manufacturing. These facilities are designed to provide appropriate levels of cleanroom technology, and are validated to ensure compliance with all applicable standards.
Entities that doe not routinely develop or manufacture biotech products may not have appropriate dedicated facilities. When such entities need cleanroom space, the problems associated with designing, building and validating the space may be prohibitive in both time and cost.
A need therefore exists for a mobile, modular cleanroom facility that can be pre-designed, pre-constructed, and pre-validated, and can then be transported to a selected location to provide cGMP-compliant workspace for developing and/or manufacturing cleanroom-sensitive products. The present invention addresses that need.